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The FDA ordered Meridian to review its manufacturing investigations and provide analyses of its processes for spotting quality problems and validating component designs.

"Your own data show that you received hundreds of complaints that your Epipen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died," the FDA wrote.

Therefore, your firm does not adequately analyze processes to identify existing and potential causes of nonconformities related to product or other quality problems."